HHS has announced the ten drugs that will be included in the first year of the Inflation Reduction Act’s new Drug Price Negotiation Program. They are: Eliquis (apixaban, Bristol…
HHS has announced the ten drugs that will be included in the first year of the Inflation Reduction Act’s new Drug Price Negotiation Program. They are: Eliquis (apixaban, Bristol…
The Inflation Reduction Act’s Medicare Drug Price Negotiation Program will kick off next week. The statute sets a deadline of September 1, 2023 for the Secretary of Health and Human…
On August 18, Samsung Bioepis Co., Ltd. (“Samsung Bioepis”), filed a petition for Inter Partes Review, IPR2023-01312, challenging the validity of claims 1-18 of U.S. Patent No….
On August 7, 2023, Formycon AG and Fresenius Kabi announced that they have reached a settlement with Johnson & Johnson (“J&J”) in the United States relating to FYB202, a…
Last week, Regeneron filed a motion to terminate IPR2023-00620, an IPR filed by Celltrion on February 28, 2023, seeking cancellation of claims 1-4 of Regeneron’s U.S. Patent No. 10,406,226 which…
We previously reported on the opening post-trial briefs in Regeneron’s BPCIA case against Mylan and Biocon (who was added as a defendant after the original defendant, Mylan, transferred its…
On July 19 and 20, 2023, the PTAB granted institution of IPR2023-00442, filed by Samsung Bioepis regarding Regeneron’s Patent No. 10,130,681 which is directed to treating angiogenic eye…
In the last week, seven adalimumab biosimilars referencing HUMIRA entered the U.S. market: Boehringer Ingelheim’s CYLTEZO (adalimumab-adbm); Sandoz’s HYRIMOZ (adalimumab-adaz); Organon…
On June 29 and 30, 2023, respectively, Formycon AG (“Formycon”) and Celltrion Inc. (“Celltrion”) announced submission to the FDA of aBLAs for their aflibercept biosimilar candidates….
Samsung recently filed the following IPR petitions challenging all claims of four patents assigned to Alexion relating to SOLIRIS (eculizumab): IPR2023-00998, challenging claims 1-3 of U.S….